TABLE 4.
Records retrieved from Clinicaltrials.gov investigating the effects of orally administered LF in the prevention and/or management of viral infections
| Principal investigator, identifier | Title | Country | Start date, Completion date | Condition or disease, virus | Purpose/Outcome | Recruitment status |
|---|---|---|---|---|---|---|
| Cleary, NCT00560222 | Randomized, controlled trial—LF prevention of diarrhoea in children | Perù | Feb 2008, Oct 2011 | Diarrhoea and malnutrition | To determinate the effect of bLF on diarrhoea prevention and on growth in intervention group of healthy children versus placebo group | Completed and published 44 |
| Allen, NCT01092039 | XIGO effectiveness study: An investigation of the safety and efficacy of oral XIGO tablets on patients diagnosed with the common cold | United States | Mar 2010, Apr 2011 | Common cold | To assess symptoms severity and resolution after bLF administration in intervention group of patients with cold versus placebo group | Completed |
| Baker, NCT01830595 | Recombinant LF to reduce immune activation and coagulation among HIV positive patients | United States | Sep 2014, Jan 2018 | HIV | To evaluate effectiveness of bLF in reducing inflammation (IL‐6, D‐dimer, CD‐16, sCD163) in intervention group of HIV infected patients versus placebo group | Completed and published 42 |
| Campione,NCT04475120 | Interventional pilot study to assess the use of oral and intra‐nasal liposomal LF in COVID‐19 patients with mild‐to‐moderate disease and in COVID‐19 asymptomatic patients | Italy | Apr 2020, Jul 2020 | SARS‐CoV‐2 | To assess the efficacy of liposomal LF in COVID‐19 patients with mild‐to moderate disease and in COVID‐19 asymptomatic patients versus no intervention groups | Completed and published 52 , a |
| Soofi, NCT04432935 | Effect of bovine LF on seroconversion following polio vaccine administration in children: A randomized control trial | Pakistan | Jun 2020, Sep 2021 (estimated) | Poliomyelitis | To evaluate the level of seroconversion in children following poliovirus vaccination after bLF administration versus placebo group | Recruiting |
| Esmat, NCT04421534 | Utility of LF as an adjunct therapeutic agent for COVID‐19 | Egypt | Jun 2020, Sep 2020 | SARS‐CoV‐2 | To study the potential application of LF against SARS‐CoV‐2 and propose the possibility of using different doses of supplemental LF as a potential adjunct treatment for COVID‐19 | Not yet recruiting |
| Hegazy, NCT04412395 | Clinical assessment of oral LF as a safe antiviral and immunoregulatory in treating COVID‐19 disease (COVID‐19_LF) | Egypt | Jun 2020,Sep 2021 (estimated) | SARS‐CoV‐2 | To clinically use bLF as a safe antiviral adjuvant for treatment and to assess the potential in reducing mortality and morbidity rates in COVID‐19 patients | Not yet recruiting |
| Esmat, NCT04427865 | Utility of LF as a preventive agent for healthcare workers exposed to COVID‐19 | Egypt | Jul 2020, Nov 2020 | SARS‐CoV‐2 | To assess the safety and efficacy of LF within the context of SARS‐CoV‐2 and propose the possibility of supplemental LF as a potential preventive drug for healthcare workers exposed to SARS‐CoV‐2 | Not yet recruiting |
| Ochoa, NCT04526821 | LF for prevention of COVID‐19 in health care workers (LF‐COVID) | Peru | Sep 2020, Nov 2021 (estimated) | SARS‐CoV‐2 | To determine the effect of bovine LF on the prevention of COVID‐19 infection | Not yet recruiting |
Abbreviations: bLF, bovine lactoferrin; COVID, coronavirus disease; LF, lactoferrin.
a
Pre‐print article.